The Treatment

Background

Traumatic Brain Injury (TBI) is the most common injury that service members experience in the combat settings of Iraq and Afghanistan, especially in those sustaining multiple exposures. The mechanisms of injury included blasts or explosions, falls, motor vehicle accidents, and fragment, shrapnel, and bullet wounds. In one survey of more than 2000 army infantry soldiers, performed three to four months after their return from a one-year deployment in Iraq, 5 percent reported injuries with loss of consciousness and 10 percent reported injuries with altered consciousness.

Symptoms

Acutely, the symptoms of concussion are confusion and amnesia, sometimes with, but often without, preceding loss of consciousness. These symptoms may be apparent immediately after the head injury or may appear several minutes later. The alteration in mental status characteristic of concussion can occur without loss of consciousness. Seizures are uncommon in mild TBI and problems such as limb weakness do not occur with mild TBI.

The majority of mTBI patients develop headache, dizziness, neuropsychiatric symptoms, and cognitive impairments, which may continue for weeks to months and in up to 25% of patients for over six months. Individuals with a history of chronic (>1-year prior) mTBI often develop emotional and cognitive dysfunction, including disturbances in mood (depression, suicide) and alterations in sleep (i.e., poor quality, changes in sleep-stage proportions)4, as below, often culminating in inability to carry out ordinary daily activities, work responsibilities and standard social relationships. Sleep complaints often occur, including insomnia, difficulty maintaining sleep, early morning awakenings and nightmares.

With the above an considerable other information in hand and despite substantial changes in the acute care of combat-related TBI in US military personnel in recent years, trends in clinical outcomes have changed very little. There is no effective treatment or pharmaceutical intervention in the daily clinical practice for post TBI, although . Intensive therapy and rehabilitation programs are considered essential for maximizing quality of life but are often only partially successful. Various novel approaches, such as hyperbaric oxygen, have demonstrated potential but remain unproven, thus highlighting a significant unmet need, and the intensive search for new methods to provide sustained relief affected patients.

USING STEM CELLS TO TREAT TBI

The mechanisms of stem cell-related repair in TBI have been studied with various types of cells, including those taken from adipose tissue and bone marrow. Over the last 7-8 years, clinical studies of stem cell-based TBI treatment have been few, most targeting patients either in the acute stage with intravenous infusion, injection into the spinal canal or direct injection into the brain (requiring surgery). Fewer have addressed the chronic mTBI patient.

Increasingly, patients seek treatment options outside of their traditional healthcare environments, many to receive stem cells and other treatments for various conditions. Stem cell clinics vary with respect to types of patients treated and types of cells used; most do not specify doses and the routes of administration and do not follow guidances or common standards for stem cell product production and administration. The development of stem cell clinics is increasing globally. Concerns have been expressed regarding marketing of services and implementing and monitoring safety standards and outcomes.

A significant shortcoming of most stem cell clinics is the failure to collect of follow-up data, a result often ascribed to logistical and financial constraints of having patients return for multiple visits from geographically remote areas. The commitment to assessing long-term outcomes is of critical importance. To our knowledge, of the clinics cited above few if any incorporate stuructured mechanisms for long term patient follow-up in TBI patients.

the Clinical Treatment Program plan at OKYANOS CENTER FOR REGENERATIVE MEDICINE

A primary mission of the Okyanos Center for Regenerative Medicine program is to assess the risks and benefits of the adult stem cells it provides, utilizing data collection and analysis methods based in scientific rigor.

Since 2015, Okyanos Center for Regenerative Medicine has utilized IV administration in patients with chronic ischemic injury and neurodegenerative conditions, without any safety concerns. Therefore, in that the efficiency of cell delivery and effects are felt to be acceptable to other patient populations, our Center has chosen the IV route for stem cell administration.

In contrast to other approaches used in treating similar patient populations with stem cell products, ours utilizes:

Intravenous dosing

Autologous SVF

Rigorous 12 month data collection and analysis

Okyanos Center for Regenerative Medicine is committed to following patient progress well after they leave the Clinic to return home.

Clinical Treatment Program and Follow Up

pre-treatment Screening

The pre-treatment screening period is the time between the the initial referral and the clinical treatment process. The Center works closely with the patient to explain the Clinical Treatment Program, answer questions, and assist in gathering necessary information.

No procedure will be performed until the patient has been completely informed of the details of the Clinical Treatment Program including its nature, risks, and procedures; has reviewed and accepted the program and followup plan; and has signed and dated an informed consent form.

TREATMENT SCHEDULE

Day 0

On the day prior to treatment, patients will come to the Center for pre-procedure assessment of clinical status, including history, physical examination, BrainCheck, PRO: SF-36 (if not performed previously) and evaluations by the anesthesiologist and plastic surgeon (for liposuction).

Day 1

The patient will undergo two sequential procedures: liposuction and IV infusion mannitol prior to that of ADRCs

Liposuction

During the liposuction, a doctor will remove a small amount of fat tissue from your belly or thigh, about 60ml, that’s about a-half stick of melted butter. This fat tissue contains your unique one-of-a-kind adult stem cells. There are a lot of them but they are trapped in fat. So over the next two hours, you’ll relax in a private patient suite while your stem cells are isolated.

IV Infusion of Mannitol SVF

Mannitol is given first to increase the number of cells that enter the brain tissue, followed by infusion of SVF. During the infusion and for 3-6 hrs after, frequent assessments of how patients are feeling, physical examinations (vital signs) and clinical assessments will occur. After this, patients will be discharged from the Center.

Days 3, 6 and 10

Phone calls will occur on Days 3, 6 and 10 to assess symptoms, medications and any adverse event occurrences, along with a visual assessment with photographs of liposuction and access sites.